U.S. patent application number 13/445184 was filed with the patent office on 2012-10-18 for method and apparatus for treating sexual dysfunction.
This patent application is currently assigned to NEOTRACT, INC.. Invention is credited to Joseph Catanese, III, Thedoore C. Lamson, Joshua Makower.
Application Number | 20120265006 13/445184 |
Document ID | / |
Family ID | 47006896 |
Filed Date | 2012-10-18 |
United States Patent
Application |
20120265006 |
Kind Code |
A1 |
Makower; Joshua ; et
al. |
October 18, 2012 |
Method and Apparatus for Treating Sexual Dysfunction
Abstract
A system and associated method for manipulating tissues and
anatomical or other structures in medical applications for the
purpose of treating sexual dysfunction. In one aspect, the system
includes a delivery device configured to deploy and implant anchor
devices for such purposes.
Inventors: |
Makower; Joshua; (Los Altos,
CA) ; Lamson; Thedoore C.; (Pleasanton, CA) ;
Catanese, III; Joseph; (San Leandro, CA) |
Assignee: |
NEOTRACT, INC.
Pleasanton
CA
|
Family ID: |
47006896 |
Appl. No.: |
13/445184 |
Filed: |
April 12, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61475516 |
Apr 14, 2011 |
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Current U.S.
Class: |
600/38 |
Current CPC
Class: |
A61B 2017/06052
20130101; A61B 17/0482 20130101; A61B 2017/0419 20130101; A61B
17/42 20130101; A61B 17/0401 20130101 |
Class at
Publication: |
600/38 |
International
Class: |
A61F 5/41 20060101
A61F005/41 |
Claims
1. A system for treating sexual dysfunction, comprising: means for
manipulating prostatic, urinary tract or male reproductive tissue
to treat sexual dysfunction; and a delivery device, the delivery
device housing the means for manipulating tissue and including
structure for permanently implanting the means for manipulating
tissue to treat sexual dysfunction.
2. The system of claim 1, wherein the means for manipulating tissue
includes an anchor assembly.
3. A method of treating sexual dysfunction, comprising: accessing
anatomy involved in male sexual function; providing a delivery
device housing an anchor assembly; identifying tissue to be
manipulated for treating sexual dysfunction; and implanting the
anchor assembly to manipulate tissue for treating sexual
dysfunction.
4. The method of claim 3, further comprising manipulating tissue to
treat benign prostatic hyperplasia.
5. The method of claim 3, further comprising manipulating tissue to
improve lower urinary tract symptoms.
6. The method of claim 3, further comprising arranging the anchor
assembly to treat bladder outlet obstruction.
7. The method of claim 3, further comprising assessing nitric oxide
levels in one or more of a prostate, a bladder and an urethra prior
and subsequent to implantation of the anchor assembly.
8. The method of claim 3, further comprising assessing Rho-Kinase
levels prior and subsequent to implantation of the anchor
assembly.
9. The method of claim 3, further comprising assessing erectile
function prior and subsequent to implantation of the anchor
assembly.
10. The method of claim 3, further comprising assessing ejaculation
function prior and subsequent to implantation of the anchor
assembly.
11. The method of claim 3, further comprising implanting a
plurality of anchor assemblies.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical devices
and methods, and more particularly to systems and associated
methods for manipulating or retracting tissues and anatomical or
other structures within the body of human or animal subjects for
the purpose of treating sexual dysfunction.
BACKGROUND
[0002] Sexual dysfunction or sexual malfunction refers to a
difficulty experienced by an individual or a couple during any
stage of a normal sexual activity, including desire, arousal or
orgasm. For men, erectile dysfunction or impotence is a sexual
dysfunction characterized by the inability to develop or maintain
an erection of the penis. There are various underlying causes, such
as damage to the nervi erigentes which prevents or delays erection,
or diabetes, which simply decreases blood flow to the tissue in the
penis, many of which are medically reversible. There are many
factors which may result in a person experiencing a sexual
dysfunction. These may result from emotional or physical
causes.
[0003] Sexual dysfunction may arise from emotional factors,
including interpersonal or psychological problems. Interpersonal
problems may arise from marital or relationship problems, or from a
lack of trust and open communication between partners, and
psychological problems may be the result of depression, sexual
fears or guilt, past sexual trauma, sexual disorders, among others.
Sexual dysfunction is especially common among people who have
anxiety disorders. Ordinary anxiousness can obviously cause
erectile dysfunction in men without psychiatric problems, but
clinically diagnosable disorders such as panic disorder commonly
cause avoidance of intercourse and premature ejaculation.
[0004] Physical damage can of course be a major contribution to
sexual dysfunction. One leading physical cause of ED is continual
or severe damage taken to the nervi erigentes. These nerves course
beside the prostate arising from the sacral plexus and can be
damaged in prostatic and colo-rectal surgeries.
[0005] In fact, the relationship between lower urinary tract
symptoms (LUTS) and sexual dysfunction is well established and
highly prevalent (Rosen R., Altwein J., Boyle P., et al. Lower
urinary tract symptoms and male sexual dysfunction: the
multinational survey of the aging male (MSAM-7). Eur Urol 2003;
44:637-49). Both disorders can impact quality of life and may share
a common pathophysiology (McVary K. Lower urinary tract symptoms
and sexual dysfunction: epidemiology and pathophysiology. BJU Int
2006;97 (Suppl 2): 23-8, discussion 44-5). The efficacy of surgical
treatments such as transurethral resection of the prostate (TURP)
on LUTS due to benign prostatic hyperplasia (BPH) is well
established. However, the effect of surgical treatment of bladder
outlet obstruction (BOO) due to BPH on sexual function is not
clear. Several authors have found that surgical treatment of BOO
can impair sexual function (Muntener, M., Aellig, S., Kuettel R.,
Gehrlach C., Susler T., Strebel R. Sexual Function after
Transurethral Resection of the Prostate (TURP): Results of an
Independent Prospective Multicentre Assessment of Outcome. European
Urology 52 (2007) 510-516; Briganti A., Naspro R., Gallina A.,
Salonia A., Vavassori I., Hurle R., Scattoni E., Rigatti P.,
Montorsi F. Impact on Sexual Function of Holmium Laser Enucleation
Versus Transurethral Resection of the Prostate: Results of a
Prosspective, 2-Center, Randomized Trial. The Journal of Urology.
Vol. 175, May 2006: 1817-1821; Arai Y., Aoiki Y., Okubo K., Maeda
H., Terada N., Matsuta Y., Maekawa S., Ogura K. Impact of
Interventional Therapy for Benign Prostatic Hyperplasia on Quality
of Life and Sexual Function: A Prospective Study. Journal of
Urology. Vol. 164, 1206-1211 October 2000.) In contrast Brooks et
al. found that sexual function can improve after surgical treatment
(Brooks S., Donovan J., Peters T., Abramas P., Neal D. Sexual
dysfunction in men after treatment for lower urinary tract
symptoms: evidence from randomized controlled trial. BMJ. Vol. 324,
May 2002).
[0006] There are a wide variety of situations in which it is
desirable to lift, compress or otherwise reposition normal or
aberrant tissues or anatomical structures (e.g., organs, ligaments,
tendons, muscles, tumors, cysts, fat pads, etc.) within the body of
a human or animal subject. Such procedures are often carried out
for the purpose of treating or palliating the effects of diseases
or disorders (e.g., hyperplasic conditions, hypertrophic
conditions, neoplasias, prolapses, herniations, stenoses,
constrictions, compressions, transpositions, congenital
malformations, etc.) and/or for cosmetic purposes (e.g., face
lifts, breast lifts, brow lifts, etc.) and/or for research and
development purposes (e.g., to create animal models that mimic
various pathological conditions).
[0007] One particular example of a condition where it is desirable
to lift, compress or otherwise remove a pathologically enlarged
tissue is BPH. BPH is one of the most common medical conditions
that affect men, especially elderly men. It has been reported that,
in the United States, more than half of all men have
histopathologic evidence of BPH by age 60 and, by age 85,
approximately 9 out of 10 men suffer from the condition. Moreover,
the incidence and prevalence of BPH are expected to increase as the
average age of the population in developed countries increases.
[0008] The prostate gland enlarges throughout a man's life. In some
men, the prostatic capsule around the prostate gland may prevent
the prostate gland from enlarging further. This causes the inner
region of the prostate gland to squeeze the urethra. This pressure
on the urethra increases resistance to urine flow through the
region of the urethra enclosed by the prostate. Thus the urinary
bladder has to exert more pressure to force urine through the
increased resistance of the urethra. Chronic over-exertion causes
the muscular walls of the urinary bladder to remodel and become
stiffer. This combination of increased urethral resistance to urine
flow and stiffness and hypertrophy of urinary bladder walls leads
to a variety of lower urinary tract symptoms (LUTS) that may
severely reduce the patient's quality of life. These symptoms
include BOO, weak or intermittent urine flow while urinating,
straining when urinating, hesitation before urine flow starts,
feeling that the bladder has not emptied completely even after
urination, dribbling at the end of urination or leakage afterward,
increased frequency of urination particularly at night, urgent need
to urinate etc.
[0009] Although BPH is rarely life threatening, it can lead to
numerous clinical conditions including urinary retention, renal
insufficiency, recurrent urinary tract infection, incontinence,
hematuria, bladder stones, and sexual dysfunction.
[0010] Surgical procedures for treating BPH symptoms include
Transurethral Resection of Prostate (TURP), Transurethral
Electrovaporization of Prostate (TVP), Transurethral Incision of
the Prostate (TUIP), Laser Prostatectomy and Open Prostatectomy.
Such invasive approaches, however, can negatively impact aspects of
sexual function including erection and ejaculation.
[0011] Minimally invasive procedures for treating BPH symptoms
include Transurethral Microwave Thermotherapy (TUMT), Transurethral
Needle Ablation (TUNA), Interstitial Laser Coagulation (ILC), and
Prostatic Stents.
[0012] More recently, a minimally invasive surgical approach
involving employing an anchor assembly to compress the prostate and
open the urethra has been found to be effective in treating BPH.
This tissue sparing procedure is designed to retract encroaching
lobes of the prostate to improve LUTS and flow rate.
[0013] There remains a need for the development of approaches and
methods that can be used for various procedures where it is desired
to lift, compress, support or reposition tissues or organs within
the body for the purpose of treating sexual dysfunction. In
particular, there is a need for an apparatus and approaches for
manipulating prostatic tissue, the urethra, and surrounding tissues
to specifically improve LUTS and sexual dysfunction.
[0014] The present disclosure addresses these and other needs.
SUMMARY
[0015] Briefly and in general terms, the present disclosure is
directed towards an apparatus and method for deploying an anchor
assembly within a patient's body for the purpose of treating sexual
dysfunction. The apparatus and anchor assembly are used to move and
hold or compress tissue involved in one or more of urinary and
sexual functions.
[0016] In one aspect, the disclosed method is intended to move and
hold or compress tissue for the purpose of treating sexual
dysfunction. Anatomy involved in male sexual function is accessed
and a delivery device is provided and housed with structure for
moving, manipulating or compressing tissue involved in sexual
function. The tissue to be treated is identified and the treatment
structure is implanted to improve sexual function. In one aspect,
the treatment structure is an anchor assembly. In related aspects
of the disclosure, approaches are taken to increase pelvic nitric
oxide (NO). Additionally, or alternatively, the disclosed method of
tissue manipulation or compression contemplates diminishing
Rho-Kinose and thereby lessen calcium sensitivity and improve
sexual function. The disclosed methods can also be performed to
improve bladder outlet obstruction in a manner resulting in a
sensory feedback through the automatic nervous system and
subsequent decreases in sympathetic tone which may have a role in
sexual function.
[0017] A system for treating sexual function is disclosed. In one
particular aspect, the system includes a means for moving,
manipulating or compressing prostatic, urinary tract or male
reproductive tissue, and a delivery device housing the means for
moving and holding or compressing tissue. The delivery device is
also equipped with structure to accomplish permanently implanting
the means for moving and holding or compressing tissue to treat
sexual dysfunction. The means can be embodied in one or more anchor
assemblies.
[0018] The apparatus of the present disclosure can also include
various subassemblies which are mobilized via an actuator or other
manually accessible structure. The operation of the subassemblies
is coordinated and synchronized to ensure accurate and precise
implantation of an anchor assembly to improve sexual function. In
one embodiment, the delivery device is embodied in a tissue
approximation assembly. The tool includes a case assembly enclosing
an anchor delivery and assembly structure, a needle spool assembly
and a suture spool assembly. Extending from the case assembly is a
shaft assembly. Also, extending through the shaft assembly are a
pusher assembly, a needle, and a cutter assembly. Operatively
associated with the needle spool and suture spool assemblies are a
needle actuator and a needle retraction actuator (e.g., a lever).
An assembly actuator is operatively associated with the anchor
assembly structure. Safety lock and lock-out structures are also
operatively associated with the needle actuator and assembly
actuator. Activation of the needle actuator accomplishes the
advancement of a needle assembly and a first component of an anchor
assembly attached to a connector member, to an interventional site.
Activation of the needle retraction actuator withdraws the needle
assembly leaving the first component of the anchor assembly at the
interventional site. Thereafter, manipulation of the assembly
actuator results in lockingly engaging a second anchor component
with the connector member and cutting the connector member below
the second anchor component.
[0019] In one particular aspect, the present invention is directed
towards a delivery device which accomplishes the delivery of a
first or distal anchor assembly component at a first location
within a patient's body and the delivery of a second or proximal
anchor assembly component at a second location within the patient
so as to manipulate tissue in a manner to improve lower urinary
tract symptoms (LUTS) and/or sexual function. The device also
accomplishes imparting tension during delivery to a connector to
hold it while attaching the proximal anchor in situ. The procedure
can be viewed employing a scope inserted in the device. Also, the
delivery device can be sized and shaped to be compatible inside a
sheath in the range of 17 to 24F, preferably a 19F sheath or
smaller.
[0020] Additionally, in a contemplated embodiment of an anchor
delivery system, actuating a needle deploy actuator results in a
needle being advanced within a patient to an interventional site.
Activating a needle retraction lever accomplishes the withdrawal of
the needle and deployment of a first anchor component of an anchor
assembly at the interventional site. Depression of a second
actuator facilitates the incorporation of a second component into
the anchor assembly and its release at the interventional site. The
anchor delivery system with its actuators and lever provide for a
single-handed, one operator delivery of a distal anchor component
and proximal anchor component spaced apart with a connector member
between them. Various locking and sequencing mechanisms are
provided for both operational as well as safety reasons.
[0021] The anchor assembly can be configured to accomplish
approximating, retracting, lifting, compressing, supporting or
repositioning tissue within the body of a human or animal subject
that relate to LUTS and sexual function. Moreover, the apparatus
configured to deploy the anchor assembly as well as the anchor
assembly itself are configured to complement and cooperate with
body anatomy.
[0022] In one embodiment, the anchor delivery device includes a
handle assembly with an actuator attached thereto. The actuator is
associated with a body of the handle assembly and is operatively
attached to the needle and structure that advances the first anchor
member. A second actuator is operatively associated with structure
that accomplishes assembling the second anchor member to the
connector member. Additionally, the handle assembly is equipped
with structure that is configured in one contemplated embodiment,
to effect the cutting of the connector member and deployment of the
first anchor member, second anchor member, and connector at an
interventional site.
[0023] Moreover, various alternative and complimentary methods of
use are also contemplated. That is, in some applications of the
invention, the invention is used to additionally or alternatively
improve flow of a body fluid through a body lumen, modify the size
or shape of a body lumen or cavity, treat prostate enlargement,
treat urinary incontinence, support or maintain positioning of a
tissue, close a tissue wound, organ or graft, perform a cosmetic
lifting or repositioning procedure, form anastomotic connections,
and/or treat various other disorders where a natural or pathologic
tissue or organ is pressing on or interfering with an adjacent
anatomical structure. Also, the invention has a myriad of other
potential surgical, therapeutic, cosmetic or reconstructive
applications, such as where a tissue, organ, graft or other
material requires approximately, retracting, lifting,
repositioning, compression or support.
[0024] Other features and advantages of the present disclosure will
become apparent from the following detailed description, taken in
conjunction with the accompanying drawings, which illustrate, by
way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a left side view, depicting one embodiment of an
anchor delivery system;
[0026] FIG. 2 is a perspective view, depicting the anchor delivery
system of FIG. 1;
[0027] FIG. 3 is a right side view, depicting the anchor delivery
system of FIG. 1;
[0028] FIG. 4 is a side view, depicting the anchor delivery system
of FIG. 3 with a portion of the casing removed and including a
scope;
[0029] FIG. 5 is a left side view, depicting the anchor delivery
device of FIG. 1 with a portion of the casing removed and including
a scope;
[0030] FIG. 6 is an exploded view, depicting components of a distal
anchor delivery assembly;
[0031] FIG. 7 is an enlarged view, depicting a proximal portion of
the needle assembly attached to the needle drive spool
assembly;
[0032] FIG. 8 is a perspective view, depicting further details of
the connector depicted in FIG. 7;
[0033] FIG. 9 is an enlarged view, depicting a distal terminal end
of a needle assembly;
[0034] FIG. 10 is an enlarged rotated view, depicting further
details of the needle of FIG. 9;
[0035] FIG. 11 is a side view, depicting a distal component and
connector of an anchor assembly;
[0036] FIG. 12 is an enlarged side view, depicting a proximal
terminal end of the connector of FIG. 11;
[0037] FIG. 13 is an enlarged view, depicting a connection between
the proximal terminal end of the connector on a spool assembly;
[0038] FIG. 14 is a cross-sectional view, depicting a first step
involving an interventional procedure;
[0039] FIG. 15A is a perspective view partially in cross-section,
depicting a distal terminal end of a delivery device;
[0040] FIG. 15B is a schematic representation approximately in
coronel plane, illustrating the angling of the anchor delivery tool
within anatomy;
[0041] FIG. 15C is an enlarged view, depicting proper placement of
treatment structure against tissue anatomy;
[0042] FIGS. 16-19 are side views, depicting unlocking and
depression of an actuator of a delivery device;
[0043] FIGS. 20 A-B are views of selected internal components of
the delivery device, depicting action of the needle and connector
spools of a delivery device;
[0044] FIG. 21 is a perspective view in partial cross-section,
depicting partial ejection of a needle assembly;
[0045] FIG. 22 is a perspective view in partial cross-section,
depicting advancement of a needle assembly;
[0046] FIG. 23 is a cross-sectional view, depicting advancement of
a needle assembly at an interventional site;
[0047] FIGS. 24A-C are perspective and partial cross-sectional
views, depicting an alternative approach to a needle assembly;
[0048] FIGS. 25A-B are partial cross-sectional views, depicting
further details concerning action of internal components of a
delivery device upon actuation of a lever assembly;
[0049] FIG. 26 is a perspective partial cross-sectional view,
depicting withdrawal of a needle assembly leaving a connector
element;
[0050] FIG. 27 is a cross-sectional view, depicting delivery of a
first component of an anchor assembly at an interventional
site;
[0051] FIGS. 28 A-B are perspective and exploded views, depicting
various components of a shaft assembly of the delivery device;
[0052] FIGS. 29-32 are perspective views, depicting components of
one embodiment of a shaft assembly;
[0053] FIGS. 33A-34 are perspective views, depicting embodiments of
a terminal end of the delivery device;
[0054] FIGS. 35-37 are perspective views, depicting contemplated
features of a cover assembly;
[0055] FIG. 38 is a schematic view, depicting further orientation
features contemplated for the delivery device;
[0056] FIGS. 39 and 40 are a perspective view and side view,
depicting one approach to a sheath mount assembly and shaft seal
assembly.
[0057] FIGS. 41 and 42 A-B are perspective views, depicting an
alternative approach to a shaft seal assembly;
[0058] FIG. 43 is a perspective view, depicting structure defining
a scope lock;
[0059] FIGS. 44-46 are perspective views, depicting features of one
embodiment of a cutter assembly of the delivery device;
[0060] FIG. 47 is a cross-sectional view, depicting positioning of
an anchor within the cutter assembly;
[0061] FIGS. 48-52 are various views, depicting further features of
a cutter assembly;
[0062] FIGS. 53-55 are perspective views, depicting proximal end
connectors of the cutter assembly;
[0063] FIGS. 56-57 are perspective views, depicting features of a
suture guide;
[0064] FIGS. 58-60 are perspective views, depicting features of a
pusher assembly;
[0065] FIGS. 61-62 are partial cross-sectional views, depicting
action of the lever permitting subsequent use of the cutter
assembly as viewed from one side of the device;
[0066] FIGS. 63-64 are partial cross-sectional views, depicting
action of internal components of an interlock assembly of the
proximal anchor actuator as viewed from the opposite side relative
to FIGS. 61-62;
[0067] FIGS. 65-67 are partial cross-sectional views, depicting
action of interval components upon activation of the proximal
anchor actuator as viewed from same side as FIGS. 61-62.
[0068] FIG. 68 is a cross-sectional view, depicting release of a
second anchor component within an interventional site;
[0069] FIG. 69 is a cross-sectional view, depicting release of an
assembled anchor assembly within an interventional site;
[0070] FIG. 70 is a cross-sectional view looking along the axis of
the urethra within an enlarged prostate, depicting an untreated
interventional site;
[0071] FIG. 71 is a cross-sectional view looking along the axis of
the urethra within an enlarged prostate, depicting implantation of
two anchor assemblies at an interventional site;
[0072] FIG. 72 is an enlarged view of a portion of FIG. 71;
[0073] FIG. 73 is a cross-sectional view, depicting another view of
two anchor assemblies implanted at an interventional site; and
[0074] FIGS. 74-76 are graphical representations, depicting results
of a sexual dysfunction treatment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0075] Turning now to the figures, which are provided by way of
example and not limitation, the present disclosure is directed to a
device configured to deliver an anchor assembly within a patient's
body for the purpose of treating sexual dysfunction. The disclosed
apparatus can be employed for retracting, lifting, compressing,
approximating, supporting or repositioning tissues, organs,
anatomical structures, grafts or other material found within a
patient's body. Such tissue manipulation is intended to facilitate
the treatment of diseases or disorders.
[0076] In an aspect of the present invention, one portion of an
anchor assembly or implant is positioned and implanted against a
first section of anatomy. A second portion of the anchor assembly
or implant is then positioned and implanted adjacent a second
section of anatomy for the purpose of retracting, lifting,
compressing, approximating, supporting or repositioning the second
section of anatomy with respect to the first section of anatomy as
well as for the purpose of retracting, lifting, compressing,
approximating, supporting or repositioning the first section of
anatomy with respect to the second section of anatomy. It is also
to be recognized that both a first and second portion of the anchor
assembly can be configured to accomplish the desired retracting,
lifting, compressing, approximating, supporting or repositioning of
anatomy due to tension supplied during delivery via a connector
assembly affixed to the first and second portions of the anchor
assembly or implant.
[0077] As stated, the relationship between LUTS and sexual
dysfunction has been established. In contrast to traditional
surgical treatments, a tissue sparing procedure involving the
disclosed anchor assembly that improves LUTS and flow rate is
disclosed for treating sexual dysfunction. The method is designed
to retract the encroaching lobes of the prostate by the use of
small anchors placed through the prostate tissue so as to sit at
the prostatic capsule. Each anchor positioned at the prostatic
capsule is attached to a second anchor that is positioned against
the urethral wall. The internal urethral anchor is then placed
along a length of non-absorbable suture connecting the two anchors,
so as to retract the hyperplasic tissue between the urethral wall
and the prostatic capsule, thereby opening the prostatic urethra
and relieving the obstruction. Because the urethral anchor is a
small, thin-walled structure that is pushed into the urethral wall,
no excess material (such as is found with cylindrical stents)
protrudes from the urethral wall to act as a nidus for encrustation
such that there is a positive impact on erectile and ejaculatory
function.
[0078] Long established surgical treatments such as simple
prostatectomy and TURP can cause retrograde ejaculation and
negatively impact all aspects sexual function including erection
and ejaculation. The disclosed minimally invasive treatment for
LUTS that, in contrast to other surgical treatments is tissue
sparing and involves anchors delivered transurethrally to separate
the lobes of the prostate that encroach on the urethral lumen. By
separating these lobes, the urethral lumen is expanded thus
improving flow and IPSS.
[0079] It has been found that the disclosed approaches and method
improves both erections and ejaculation. This improvement occurs
shortly after surgery and appears to be durable for at least 6
months. Nitric oxide (NO) is known to be deficient in the prostate,
bladder, and urethra in patients with BOO and the proposed method
is intended to decrease NO. The proposed method is also intended to
act through the Rho-kinase pathway. There can be increased
Rho-kinase and thereby calcium sensitivity in the prostate smooth
muscle in men with BPH and in the corpora cavernosa in men with ED.
By improving LUTS, Rho-kinase can be diminished which would lessen
calcium sensitivity and improve erections. An improved global
satisfaction in health which is reflected in a nonspecific fashion
can also favorably affect sexual outcomes. Finally, by improving
BOO there is a sensory feedback through the autonomic nervous
system and subsequent decrease in sympathetic tone which may
improve erectile function.
[0080] Referring now to FIGS. 1-3, there is shown one embodiment of
an anchor delivery device 100 which can be used to treat sexual
dysfunction. This device is configured to include structure that is
capable of both gaining access to an interventional site as well as
assembling and implanting one or more anchor assemblies or implants
within a patient's body. In one embodiment, the device 100 is
configured to assemble and implant a single anchor assembly or
implant. The device is further contemplated to be compatible for
use with a 19F sheath. The device additionally includes structure
configured to receive a conventional remote viewing device (e.g.,
an endoscope) so that the steps being performed at the
interventional site can be observed.
[0081] Prior to use of the present device 100, a patient typically
undergoes a five day regiment of antibiotics. A local anesthesia
can be employed for the interventional procedure. A combination of
an oral analgesic with a sedative or hypnotic component can be
ingested by the patient. Moreover, topical anesthesia such as
lidocaine liquids or gel can be applied to the bladder and
urethra.
[0082] The anchor delivery device 100 includes a handle assembly
102 connected to an elongate tissue access assembly 104. The
elongate tissue access assembly 104 houses components employed to
construct an anchor assembly and is sized to fit into a 19F
cystosopic sheath for patient tolerance during a procedure in which
the patient is awake rather than under general anesthesia. The
tissue access assembly is stiff to allow manual compression of
tissue at an interventional site by leveraging or pushing the
handle assembly 102.
[0083] The anchor delivery device 100 further includes a number of
subassemblies. A handle case assembly 106 including mating handle
parts which form part of the handle assembly 102. The handle
assembly 102 is sized and shaped to fit comfortably within an
operator's hand and can be formed from conventional materials.
Windows can be formed in the handle case assembly 106 to provide
access to internal mechanisms of the device so that a manual
override is available to the operator in the event the
interventional procedure needs to be abandoned.
[0084] In one embodiment, the delivery device 100 is equipped with
various activatable members which facilitate assembly and delivery
of an anchor assembly at an interventional site. A needle actuator
108 is provided and as described in detail below, effectuates the
advancement of a needle assembly (loaded with a first component of
an anchor assembly) to an interventional site. In a preferred
embodiment, the needle assembly has a needle that moves through a
curved trajectory and exits the needle housing in alignment with a
handle element, and in particular embodiments, in alignment with
the grip. In various other embodiments, the needle housing is
oriented such that the needles exits the housing at either the two
o'clock or ten o'clock positions relative to a handle grip that is
vertical. A needle retraction lever assembly 110 is also provided
and when actuated causes the needle assembly to be withdrawn and
expose the first anchor component. This action and the structure
involved is also described in detail below. Finally, the delivery
device 100 is equipped with a rear or proximal anchor actuator
assembly 112 which as fully described below, upon actuation,
accomplishes assembly of a second component to the anchor assembly
and release of the anchor assembly at the interventional site.
[0085] Turning now to FIGS. 4-5 in addition to FIGS. 1-3, a number
of the subassemblies of the delivery device 100 are introduced, the
function and structure of each of which are addressed in detail
below. In the embodiment depicted, the case assembly 106 has three
mating parts, a left top case 114, a left bottom case 116, and a
right case 118. It is within the scope of the present disclosure
that the case assembly be made of a variety of numbers of parts. In
addition to mating to enclose subassemblies, the case parts also
include structural features for providing rigidity and support for
the enclosed components.
[0086] Housed within the case assembly 106 are a distal anchor
delivery mechanism 119 including a needle spool assembly 120 and a
suture spool assembly 122 (referred to interchangeably herein as
connector spool assembly 122). The rotational axes of the needle
spool assembly and suture spool assembly are the same. A shaft
assembly 124 includes a portion residing within the case assembly
106 and a portion extending from a forward end of the case
assembly. Attached to and operatively associated with the shaft
assembly 124 is a proximal anchor drive assembly 126. The drive
assembly 126 is also housed within the case assembly 106. FIGS. 4
and 5 illustrate the juxtapositional relationships of the various
subassemblies.
[0087] With reference to FIG. 6, details concerning an embodiment
of the structure of a distal anchor delivery mechanism 119 are
presented. As described further below, the needle spool assembly
120 cooperates with the needle actuator 108 and needle retraction
lever 110 to advance and then withdraw a needle assembly at an
interventional site.
[0088] The needle spool assembly 120 is a generally disc-shaped
structure having a number of landings and projections for engaging
and receiving various structures of the distal anchor delivery
mechanism 119.
[0089] A needle deploy spring 206 functions to rotate the needle
spool 120 (referred to interchangeable herein as connector spool
120) and to project a tip of the needle through tissue with force
and speed. One end of the deploy spring 206 is attached to the
device casing and the opposite end is engaged with a shuttle 215.
The shuttle 215, in turn, is operatively and releasably associated
with the needle spool assembly 120. In one approach, it is
contemplated that the device 100 be configured so that the needle
is deployed to a single depth to pierce through a predominant
population of urethral-prostatic distances in patients having an
enlarged prostate.
[0090] The assembly further includes a needle deploy pawl 222 which
is operatively associated with the needle actuator 108. As shown
and described below, the needle actuator pivots the needle deploy
pawl 222 away from engagement with the needle spool assembly 120,
thereby permitting rotation of the same. The rotation of the needle
spool assembly 120 is accomplished by forces generated by the
deploy spring 206.
[0091] An unsheathing pawl 224 is also provided and configured at
one end to engage the needle spool 120. At another end of the
unsheathing pawl 224 there is structure configured to engage the
suture spool assembly 122 (described below) to thereby fix its
rotational position while the needle spool assembly 120 rotates. A
tension spring 226 is positioned within a center bore of the suture
spool 122 to provide tension to a connector or suture projecting
from the suture spool 122. A lever lock and tape 228 is also
provided to lock the lever 110 until after actuation of the needle
actuator 108. The lever lock and tape 228 has a central axis or
rotating point which is common with that of the needle spool 120
and suture spool 122 assemblies and also functions to retract a
needle assembly upon depression of the lever 110. Also shown in
FIG. 6 is the needle assembly 230.
[0092] As shown in FIGS. 7 and 8, a proximal end of a needle
assembly 230 can be sized and shaped for connecting with the needle
spool 120. In one approach, the proximal end 232 of the needle
assembly 230 is equipped with a needle end bracket 234 for receipt
within a corresponding recess formed near a periphery of the needle
spool 120. Through such connections, rotation of the needle spool
120 can result in advancing and withdrawing lengths of a needle
assembly. In this regard, as shown in FIG. 7, a peripheral recess
formed in the needle spool 120 is provided to take up lengths of a
needle assembly. Further, a recess 236 is formed in the needle end
bracket 234 for guiding a proximal end of a connector of an anchor
assembly to within a channel 238 formed in the needle spool 120.
The needle spool channel 238 provides a path to the suture spool
122 (as described below).
[0093] A distal end 240 of a generally tubular needle assembly 230
is shown in FIGS. 9 and 10. The distal end 240 defines a sharpened
profile for piercing through tissue. In one particular approach,
the distal end 240 embodies a 23.degree. primary bevel geometry and
a heal 242 of the bevel so as to closely match a 0.015'' diameter
connector structure of an anchor assembly. In this way, potential
snags between the connector structure and needle assembly can be
minimized or avoided.
[0094] One form of a distal anchor 350 and connector member 352 of
an anchor assembly is shown in FIG. 11. It is the proximal end of
the connector 352 which is fixed to the suture spool 122 by a
ferrule 314 (See FIGS. 12 and 13). An annular space formed about
the suture spool 122 is provided to receive a length of the pusher
354. The ferrule termination 314 offers a secure and inexpensive
method for attaching the connector assembly 352 to the suture spool
122. The ferrule 314 can be easily pressed into receiving features
of the spool assembly 122 and can be readily removed after the
device is test fired on the production line. In an alternative
embodiment, the connector to the suture spool can also define a
plastic molded snap ferrule. In other alternative embodiments, the
ferrule 314 can be replaced with an over molded component or an
integral feature such as a bump in the connector member 352.
[0095] In one particular, non-limiting use in treating a prostate
to improve LUTS (See FIG. 14), the elongate tissue access portion
104 of a delivery device can be placed within a urethra (UT)
leading to a urinary bladder (UB) of a patient to position the
device for implanting one or more anchor assemblies. Prior to the
procedure, a transrectal ultrasound (TRUS) is contemplated to be
performed. Using a transverse view, measurements will be made to
determine the distances between the urethra and the prostatic
capsule and to determine the extent of any middle lobe obstruction.
Following induction of anesthesia, the patient can be placed in
lithotomy position, prepped and draped as standard operating
procedure. Cystourethroscopy can then be performed using a 19F
cystoscope sheath, in the standard manner. The anchor delivery
device pre-loaded with an anchor is then passed down the lumen of
the sheath in the same manner as a resectoscope. The cystoscope is
then positioned at the hyperplastic lobe and then rotated to the
pre-determined direction (typically 2 o'clock or 10 o'clock), using
the transverse prostatic measurements gained by TRUS. Applying firm
pressure against the wall of the preferred lateral lobe, a 19 gauge
needle can then be advanced from the delivery device and passed
through the prostate tissue and pubic fascia so that the needle is
positioned just outside the prostatic capsule. Fluoroscopy and/or
TRUS can be used to assure that the needle is deployed in the
correct trajectory and did not enter the bladder. Once satisfactory
needle deployment is achieved, the capsular anchor is delivered
through the needle by advancing a delivery pusher, situated within
the needle. The needle is then retracted, and the suture is
tensioned automatically. The urethral anchor was then deployed at
the desired point against the prostatic urethral wall under direct
endoscopic guidance, so as to retract the anchored lobe and open
the urethra. During urethral anchor deployment, the excess suture
is trimmed and the anchor released into position against the
urethra. After cystoscopic confirmation of satisfactory retraction
of the anchored lobe, the procedure can be repeated on the
contralateral side, if necessary. An assessment can be conducted to
determine the number of implants to be placed in each lateral lobe.
On completion of the procedure, a cystoscope was introduced to
evaluate any immediate retraction of the lateral lobes. A
post-operative transverse TRUS image is then completed for
comparison with the pre-operative view. Pre and post-operative
cystoscopic images can also be taken.
[0096] In one particular approach, the delivery device can be
placed within an introducer sheath (not shown) previously
positioned in the urethra or alternatively, the delivery device can
be inserted directly within the urethra. When employing an
introducer sheath, the sheath can be attached to a sheath mount
assembly (described below). The patient is positioned in lithotomy.
The elongate portion 104 is advanced within the patient until a
leading end 400 thereof reaches a prostate gland (PG). In a
specific approach, the side(s) (i.e., lobe(s)) of the prostate to
be treated is chosen while the device extends through the bladder
and the device is turned accordingly. The device is first
positioned at the bladder neck and then retracted approximately 1
cm while keeping the device parallel to the prostatic fossa and
preserving mucosa. As shown in FIG. 15 A, when so placed, the
distal end 240 of the needle assembly is withdrawn within the
leading end 400 of the device. The distal end of the elongate
portion can be used to push the urethra into the prostate gland.
The inside of the prostate gland (i.e., adenoma) is spongy and
compressible and the outer surface (i.e., capsule) of the prostate
gland is firm. By the physician viewing with the endoscope, he/she
can push the urethra into the prostate gland compressing the
adenoma and creating the desired opening through the urethra. To
accomplish this, the physician rotates the tool anterior between 9
and 10 o'clock for the patient's side left lobe and between 2 and 3
o'clock for the patient's side left lobe. The physician then pivots
the tool laterally about the pubic symphysis PS, generally about 20
to 30 degrees relative to the patient's midline (See FIG. 15B which
depicts an image approximately in coronal plane). Viewing through
the endoscope, the physician wants to have about the same amount of
tissue protruding on both sides of the elongate shaft (See FIG.
15C).
[0097] As shown in FIGS. 16 and 17, the delivery device is at this
stage configured in a ready state. The needle actuator 108 and the
needle retracting lever 110 are in an inactivated position. The
needle actuator 108 is locked by a pivoting safety mechanism 402 in
an inactive position. To unlock the needle actuator (See FIGS. 18
and 19), the safety mechanism 402 is rotated out of engagement with
the needle actuator 108 by applying a lateral force on a projection
of the safety mechanism 402.
[0098] Upon depression of the needle actuator 108 (FIG. 19), an
upper end of the actuator 108 engages and rotates the needle deploy
pawl 222 out from engagement with the needle spool 120 (See FIGS.
20A and B). This action overcomes the friction with needle spool
120. Disengagement of the deploy pawl 222 from the needle spool
120, permits the needle deploy spring 206 through its connection
via the shuttle 215, to rotate the needle spool 120. The needle
spool 120 rotates until the unsheathing pawl 224 catches an
external surface of the suture spool 122 and until the needle spool
120 bottoms out against the case 228. At the end of the needle
stroke, the lever lock and tape 228 becomes disengaged from the
right case 118. The shuttle in this embodiment disengages from the
needle spool so the needle deploy spring 206 can no longer apply a
force to the needle spool 120 via the shuttle 215.
[0099] At the leading end 400 of the delivery device, as shown in
FIGS. 21 and 22, such action results in the needle assembly being
advanced from within the elongate member 104. As is to be
appreciated, the needle is ejected by the needle deploy spring 206
in this embodiment in a direction commensurate with the direction
the handle assembly extends. Moreover, the needle assembly can be
configured so that it curves back toward the handle as it is
ejected. In use in a prostate intervention (See FIG. 23), the
needle assembly 230 is advanced through and beyond a prostate gland
(PG). To facilitate the same, the device can be pivoted 20.degree.
to 30.degree. laterally (pivoting about pubic symphisis).
Additionally, the device can be rotated anteriorly to lift a
prostatic lobe (as described previously). The spring deployment
helps to ensure the needle tip passes swiftly through the tough
outer capsule of the prostate without "tenting" the capsule or
failing to pierce the capsule. In an alternate embodiment, the
needle could be manually deployed by the user. In one approach, the
needle 230 is made from Nitinol tubing and can be coated with
Parylene N. Such a coating helps compensate for frictional or
environmental losses (i.e. wetness) which may degrade effectiveness
of needle penetration.
[0100] It is also contemplated that the needle assembly 230 can
include an integral tip and capsular anchor 231 which is releasably
configurable at a distal end of the needle assembly 230 (See FIGS.
24A-C). Upon needle retraction, the tip-anchor 231 remains on an
outside of a prostate capsule. The tip-anchor 231 can have a solid
tissue piercing surface providing increased strength and structure
for passing through tissue. Moreover, being configured to be
released from a proximal length of the needle assembly 230, such a
proximal portion can assume a smaller diameter since the capsular
anchor 231 does not need to reside within the needle assembly 230.
A smaller profile needle assembly can in turn lead itself to
providing more flexibility in delivery apparatus structure and aid
in advancing the assembly to an interventional site. This approach
also can avoid any interference which may occur with an approach
involving ejecting an anchor from within a hollow needle. Further,
the tip-anchor 231 can include a slot 233 which facilitates
flipping of the anchor into a position on the outside of a prostate
capsule.
[0101] After complete depression of the needle actuator 108 and the
unlocking of the needle retraction lever 110, the needle retraction
lever 110 can be actuated (See FIGS. 25A-B). When so actuated, the
tape portion of the lever lock and tape 228 cooperates with the
lever 110 to rotate the needle spool 120 in an opposite direction
while the suture spool 122 is held stationary. Such action results
in a withdrawal of the needle assembly 230, leaving the connector
352 of an anchor assembly in an extended position (See FIG. 26). In
one embodiment, the needle 230 is withdrawn further than its
original position within the device pre-deployment. When extended,
the connector 352 extends through the needle window and is centered
by suture guide structure (as described below). As shown in FIG.
27, in a prostatic interventional procedure, the same results in
delivering a first or distal anchor component attached to the
connector 352 beyond an outer surface of a prostate gland (PG) with
the connector 352 within a penetration tract in the prostate gland
extending toward the terminal end 400 of a delivery device.
[0102] The tensioning spring 226 provides the tension forces which
helps to ensure the distal anchor is pulled back into firm contact
with a desired tissue plane such as, for example, the outer
capsular surface of the prostate gland (FIG. 25A). Notably, the
spring in a preferred embodiment provides a force such as up to 1-2
pounds or more of tension. In another embodiment, a spring can be
used to automatically retract the needle assembly.
[0103] The timing of the needle retraction and tensioning is
accomplished through the interaction of the unsheathing pawl 224
and the suture spool 122. As shown in FIGS. 20A-B, 24 and 25, the
unsheathing pawl 224 is configured to permit a rotation of the
suture spool 122 which occurs during needle actuator depression
until the unsheathing pawl 224 registers within grooves formed in
the suture spool 122. Actuation of the needle retraction lever 110
causes a deflection of the unsheathing pawl 224 (See FIG. 25B)
which disengages the unsheathing pawl 224 from the suture spool
122. Since the suture spool 122 is at this point disengaged from
the operation of the spring arbor as described above, the suture
spool 122 is permitted to rotate in an opposite direction. This
rotation continues until the suture spool bottoms out on the needle
spool 120. Complete depression of the lever 110 also then results
in the lever locking against the case assembly 106. The tensioning
spring 226 is then left to automatically provide a consistent
tensioning force on a connector of an anchor assembly. Such
tensioning results in seating a distal or first anchor component
350 as desired within an interventional site such as shown in FIG.
27 as well as to minimize a distance between two anchor members of
an implanted anchor assembly. The tension generated after seating
the anchor component 350 can be different from that during delivery
of the connector of the anchor assembly.
[0104] A more detailed description of the shaft assembly now
follows as does a description of the operation of the structure
achieving assembly of a second or proximal anchor component to a
connector of an anchor assembly and release of a complete anchor
assembly at the interventional site.
[0105] With reference to FIGS. 28A-B, there is shown an embodiment
of a shaft assembly 124. Components of the shaft reside within the
device case assembly 106 and include structure attached to and
cooperating with proximal anchor delivery and assembly structure. A
terminal end portion 400 of the shaft assembly 124 includes an
atraumatic distal tip 502. Proximally located to the tip 502 is a
tubular shaft assembly 504 which is sized and shaped to slidably
receive the needle assembly. An internal portion of the tip 502 is
curved so that a needle projecting therefrom extends in a direction
generally corresponding to that of a handle element of the delivery
device. Configured longitudinally adjacent the tubular shaft
assembly is a scope tube 506 which is sized and shaped to receive a
scope as described previously. Configured below and longitudinally
adjacent the scope tube 506 is an elongate cover 507 which is sized
to receive elongate portions of the cutter and pusher
assemblies.
[0106] As shown in FIGS. 29-32, the shaft assembly 124 can
alternatively be formed from modular pieces. For example, a
telescope tube 506 can be employed as a backbone about which a
molded tip 502 and a shaft extension 509 are configured. An
atraumatic tip sleeve 591 can be placed over the tip 502 and an
elongate cover 507 can be placed longitudinally along the shaft
extension 509. This modular shaft assembly permits the use of
injection molded components to form the shaft. Injection molded
components are less expensive and can lead themselves to easy and
quick assembly. Moreover, different materials can be chosen for the
various shaft components to thereby provide desired shaft
stiffness. Further, in one contemplated approach, a clear sheath
hood 515 can be configured about the distal tip 502 so that a
matching of a sheath and a distal portion of the device can be
better accomplished.
[0107] During use of the present device, viewing of the
interventional site is accomplished through a telescope which can
involve a foreshortening effect in the field of view. In addition,
because of the speed of the needle and the end of the tool being
pressed into the tissue and the lobes protruding on each side, the
operator may not know or see where the needle assembly will exit
the device and/or engage tissue. Therefore, a needle directing
arrow 511 can be included on the tip 502. The distal tip 502 can
also include indicators which facilitate providing the operator
with further orientation guides. In one approach (FIG. 33A), an
indicator 513 can be placed on lateral projections of the tip 502.
Another approach can involve an indicator 513 defining a laterally
directed arrow 511 (See FIG. 33B). Thus, the tip indicator 513 can
be pushed directly against tissue to show where the needle will
exit and subsequently where a proximal anchor will land. In yet
another approach (FIG. 34), a reflective surface 518 can be
configured on the distal tip 502 distal to where the connector
exits the tip 502. In this way, light can be reflected back onto
the connector to thus light up the area and improve visualization
of the connector when the area is dark. A circular, elliptical,
parabolic or straight cut can be made and provided with a
reflective surface. These features can alternatively be
incorporated into a cover assembly as a separate part or adhered to
the cover with atraumatic tape or be part of the tap itself. The
features in some embodiments take advantage of a light source
associated with the viewing apparatus being employed and reflect
light back providing a bright appearance. The relatively
perpendicular angle of the indicators with respect to the light
source results in significant contrast. In one embodiment, a small
fiber optic resides in the shaft assembly, such as parallel to the
cover on the outside or inside the cover parallel to the cutter,
using the same light source as the endoscope/telescope. The fiber
can have a right angle output so that the light shines onto the
tissue.
[0108] In another approach to providing the operator with
orientation, as stated, the cover 507 can include indicators. As
shown in FIGS. 35-37, the cover 507 can include indicators 513 on
faces generally perpendicular to the viewing orientation. It is to
be noted that such indicators can assume various shapes such as
rectangles and arrows.
[0109] In a related approach (See FIG. 38), the present device can
include vertical indicators 517 to aid in keeping a connector of
the anchor assembly centered relative to a proximal anchor
component during assembly and delivery of the anchor assembly.
There is a controlled delay between the application of tension to a
connector and the delivery of a proximal anchor at an
interventional site. During this delay, the connector can
potentially get off-center or move too far distal relative to the
proximal anchor component. The vertical lines 517 thus aid an
operator with manually guiding the connector into an optimal
position such as placing the connector parallel to or between the
vertical line indicators 517. The indicators can be formed from
small wires running vertically in the scope view distal of the
scope and proximal of a centered connector position. The tip or
cutter can also be modified to include such vertical lines formed
for example, by etching.
[0110] With reference to FIGS. 39-40, at a proximal end of the
shaft assembly 124 is a sheath mount assembly 510 including a screw
lock 512. Configured to extend through this structure are proximal
portions of a cutter assembly 514 and a pusher assembly 516. Both
the cutter and pusher assemblies include elongate portions
extending toward a distal end 400 of the shaft assembly 124. The
screw lock 512 of the sheath mount assembly 510 can be screwed to a
terminal end of an introducer sheath assembly (not shown). The
sheath mount 510 can include an elongate seal 519 (FIG. 40) which
functions to seal and minimize fluid ingress into the handle
portion of a delivery device. A proximal end of the seal 519
includes a lateral extension 521 which engages a proximal surface
of the sheath mount to prevent the seal 519 from migrating distally
and potentially jamming or stalling the cutter or pusher. In
another approach (FIGS. 41-42B), a disc-like seal 530 is configured
to be captured between the sheath mount 510 and case halves during
assembly. The seal 530 restricts the flow of fluids (i.e., saline
or irrigation solution) through the cutter/pusher area via a thin
wiper feature. The seal 530 slightly compresses into the sheath
mount 510 and is indexed over an outer profile of the shaft 124.
The seal 530 stretches over the shaft and has a 0.010 inch thick
wiper element 532 at the cutter/pusher interface to limit friction
and reduce fluid flow.
[0111] As shown in FIG. 43, the scope mount screw lock assembly 508
(See also FIGS. 1-5) includes a screw lock 520 for mating with the
casing of the present device and a central opening for receiving a
scope 549 which has a longitudinal dimension sufficient to extend
longitudinally substantially a length of the scope tube 506. The
central opening is shaped to lockingly receive the scope. The screw
lock 520 includes two pairs of cantilevers 523 that form undersized
gaps for tabs (not shown) formed on the device casing to press
through. During use, the locks 520 remain engaged with the tabs due
to the gaps therebetween being undersized. It is intended that the
screw lock be configured so that the gap in the middle of the lock
520 places the weakest point of the lock in a position unlikely to
be pulled on by the user or operator.
[0112] As best shown in FIGS. 44 and 45, an embodiment of the
cutter assembly 514 includes elongate cutter tube 562. A distal end
568 of the cutter tube 562 is configured with a blade 569 so that
once the cutter assembly 514 is withdrawn, the blade can sever as
desired a connector of an anchor assembly. In one particular
embodiment, the cutter 514 can be formed from ground 17-4PH
stainless steel blank. Various structures are contemplated for
incorporation into the cutter assembly to facilitate a clean
severing of a connector as well as to aid in assembling a proximal
component of an anchor assembly to the connector. For example, as
best seen in FIG. 45, the cutter blade 569 includes a coined out
underside that is intended to be offset from a bottom side of a
proximal anchor by about 0.0035+0.0010 inches to cut a nominal
0.015 inch diameter connector. In this way, the proximal anchor can
exit a cutter without deforming or compressing a suture or
connector tag, and the strength of the connector to anchor
connection is maintained.
[0113] As shown in FIGS. 46-48, the cutter 514 can define a
generally rectangular elongate single body that can be formed by
stamping and bending. An interior of the body is sized and shaped
to receive a proximal anchor component 550. A proximal end portion
of the cutter 564 can further include anti-buckling tabs 551 and
extensions 553 intended to snap fit to a cutter block (described
below). Lance-out structures 555 are also contemplated to be spaced
along the cutter body which facilitate alignment of the cutter 514
within the shaft assembly.
[0114] To eliminate snagging of a connector, walls defining a
needle window 557 formed in the cutter 514 can be contoured to help
properly guide the connector into a suture capture area 559. As
best seen in FIG. 49, a proximal portion of the needle window 557
defines a gradual slope for directing the connector within the
capture area 559. In a related approach (FIG. 50), bumps 561 can be
formed on connector guiding structure to further aid in properly
positioning a connector 352 for engagement with a proximal anchor
component 555.
[0115] Moreover, as depicted in FIGS. 51 and 52, the cutter 214 can
further include skew limiting projections 563 extending internally
within the generally tubular cutter 214. As best seen in FIG. 52,
the projections 563 help to maintain proper positioning of a
proximal anchor component 555 within the cutter 214.
[0116] Approaches to attaching the cutter 214 to a cutter block 565
are shown in FIGS. 53-55. As shown in FIG. 53, a point of potential
buckling 567 of the cutter assembly can coincide with its
connection to a cutter block 565. To offset such buckling, the
anti-buckling tabs 551 can be configured adjacent a distal face of
the cutter block 565 (FIG. 54). Such anti-buckling tabs 551 can
alternatively or additionally be folded at a 30.degree. angle to
help index the cutter with respect to the cutter block 565. In each
of these approaches, the extensions 553 snap fit to receiving
structures of the cutter block 565.
[0117] In a further aspect, the present device can include a suture
alignment slide 570 configured to slide under a cover 571 and over
the cutter 514. The cover 571, in turn, includes a finger projector
573 which is sized and shaped to control and guide the movement of
a proximal anchor 555. The alignment slide 570 indexes the
connector 352 to a centerline of the cutter 514. It also operates
to pull the connector 352 proximally for indexing within the
proximal anchor component 555 to thus enhance connector capture by
the anchor component 555. In other embodiments, a distal end of the
needle housing itself can alternatively or additionally include a
slot or notch for properly registering the connectors during device
use and particularly when tension is being applied to the
connector.
[0118] In order to accomplish the attachment of the proximal anchor
555 to the connector 352, a pusher assembly 575 is configured to
extend within the cover 571 (See FIGS. 58-60). The pusher assembly
525 can include a proximal portion 577 which extends to the handle
of the device (connected to pusher block as described below) and a
distal portion 579 which attaches to the proximal portion 577. The
distal portion 579 can further include an extension 581 sized to
receive the length of a proximal anchor 555. The thickness of the
extension 581 is chosen to ensure a 0.004 inch gap between a cutter
and a bottom portion of the proximal anchor 555 so that a connector
tag remains after its severing by the cutter. The cover 571 can
further include an anchor stop 583 which is configured at a distal
end of the cover 571. The anchor stop 583 is sized and shaped to
protect the proximal anchor 555 from becoming trapped within the
cover 571 after its engagement with the proximal anchor 555.
[0119] Details of an embodiment of the proximal anchor drive
assembly 126 are depicted in FIGS. 61-67. The proximal anchor drive
126 includes the cutter block 565 operatively connected to a pusher
block 604 by a spring 606. Longitudinal motion of each of the
cutter and pusher blocks 565, 604 are guided by recesses formed in
the casing 106 of the device. A cutter pawl 608 is further provided
to control the timing of the action of the cutter and pusher blocks
565, 604. Initially, the operation of the proximal anchor drive 126
is locked out by the lever 110 (FIG. 61) as well as the proximal
anchor actuator assembly 112. Upon depression of the lever 110 as
described above in connection with the refraction of the needle,
the lever 110 is moved such that its engagement with the cutter
pawl 608 is removed (FIG. 62). It is in this condition that the
proximal anchor drive 126 can be activated once the proximal anchor
actuator assembly 112 is unlocked.
[0120] The proximal anchor actuator assembly 112 is configured at a
back end of the casing 106 and includes a pusher pawl 610 and a
pusher pawl interlock 612 (See FIGS. 63 and 64). The pusher pawl
interlock 612 can be unlocked by the retraction lever 110 away from
engagement with the pusher pawl 610 to thereby unlock the proximal
anchor drive 126. Next, the pusher pawl 610 can be rotated by the
operator to activate the proximal anchor drive 126 (See FIGS. 65
and 66). By so rotating the pusher pawl 610, the pusher block 604
is released and the spring 606 causes the pusher block 604 to slide
forwardly. Through its connection to the pusher of the pusher block
604, the pusher assembly 575 is advanced distally which, in turn,
results in the proximal anchor component 555 engaging the connector
352 (See also FIG. 60).
[0121] Next, the pusher block 604 contacts a first end of the
cutter pawl 608 causing its second end to rotate away from the
engagement with the cutter block 565. It is to be noted that the
timing of first advancing a proximal anchor component 555 and then
cutting a connector 352 to length can be controlled by the force
applied by the spring 606, the distance the pusher block 604 is to
travel, and/or the location of the first end of the cutter pawl
608. A proximal end of the cutter 214 is attached to the cutter
block 565. As the cutter block 565 moves proximally, the cutter 214
is withdrawn.
[0122] Accordingly, release of the pusher assembly advances the
second component 555 of an anchor assembly into locking engagement
with a connector of an anchor assembly (See FIG. 60). Such action
causes the pusher 575 to advance the anchor component 555 onto a
connector (e.g., a suture) while the connector is being held by the
tool with sufficient force and the anchor is advanced with
sufficient speed and force to seat the anchor 555 with reliable
retention force. Within a patient's body, as shown in FIG. 68, the
anchor assembly is configured across anatomy within the
interventional site. Upon withdrawal of the cutter assembly, the
blade portion thereof is brought across the connector 352 thereby
severing it close to the second anchor component 555 leaving a
short tag. The resultant implanted anchor assembly 700 is shown in
FIGS. 69, 71 and 72. FIG. 71 depicts a partial cross-sectional view
of the urethra (UT) widened due to the anchor assembly compressing
the surrounding enlarged prostate tissue due to the fact that the
outer capsular tissue is rather strong, substantially
non-compressible and non-displaceable while the adenoma of the
prostate gland is compressible and the urethral wall displaceable.
By way of comparison, FIG. 70 depicts a partial cross-sectional
view of an untreated interventional site of the urethra (UT)
narrowed by the surrounding enlarged prostate tissue.
[0123] The second anchor component can be embodied in a slotted
anchor configured to secure to a connector. The slotted proximal
anchor can include a flattened-tubular back end that resembles a
flattened tube in shape, with a width in lateral cross-section that
is greater than its thickness. The slotted proximal anchor also
includes a pair of spaced apart prongs extending from the back end
of the slotted proximal anchor to the front end of the slotted
proximal anchor. The spaced prongs join together at a slot
inception. The prongs are shaped and sized of a configuration and
of a rigidity to substantially prevent deflection of the prongs.
The prongs can include inwardly facing protrusions that are
configured to capture and deform the connector between the
protrusions and prevent the connector from disengaging from the
slotted anchor device once engaged. The mechanism of suture
attachment and strength of the assembly is a combination of
compression of the suture between the stiff slotted prongs of the
anchor as well as disruption of the suture surface by the discreet
edges of the slotted, flattened-tubular anchor. The discreet edges
provide a lower contact surface area between anchor prongs and
suture and focuses the compressive forces in focal points that
cause the suture to conform around both internal recesses and
external faces. It is also to be recognized that various further
embodiments of slotted anchors or anchors forming a clip are also
contemplated. In particular, various embodiments of structures
which accordingly provide alternative approaches to attach to a
connector can be employed. That is, the anchors can be deformable,
deflectable, latching, nested, meltable and/or coiled in
structure.
[0124] Accordingly, the present invention contemplates both pushing
directly on anchor portions of an anchor assembly as well as
pushing directly upon the connector of the anchor assembly.
Moreover, as presented above, the distal or first anchor component
is advanced and deployed through a needle assembly and at least one
component of the proximal or second anchor component is advanced
and deployed from a housing portion of the anchor deployment
device. Further, either a single anchor assembly or multiple anchor
assemblies can be delivered and deployed at an intervention site by
the deployment device. Additionally, a single anchor assembly
component can for example, be placed on one side of a prostate or
urethra while multiple anchor assembly components can be positioned
along an opposite or displaced position of such anatomy. The number
and locations of the anchor assemblies can thus be equal and/or
symmetrical, different in number and asymmetrical, or simply
asymmetrically placed. In the context of prostate treatment, the
present invention is used for the compression of the prostate gland
and the opening of the prostatic urethra, the delivering of an
implant at the interventional site, and applying tension between
ends of the implant. Moreover, drug delivery is both contemplated
and described as a further remedy in BPH and over active bladder
treatment as well as treating prostate cancer and prostatitis.
[0125] Once implanted, the anchor assembly of the present invention
accomplishes desired tissue manipulation, approximation,
compression or retraction as well as cooperates with the target
anatomy to provide an atraumatic support structure. In one
preferred embodiment, the shape and contour of the anchor assembly
700 is configured so that the assembly invaginates within target
tissue, such as within natural folds formed in the urethra by the
opening of the urethra lumen by the anchor assembly (See FIGS.
71-72). In fact, in situations where the anchor assembly is
properly placed, wispy or pillowy tissue in the area collapses
around the anchor structure. Eventually, the natural tissue can
grow over the anchor assembly 700 and new cell growth occurs over
time (see FIG. 69). Such cooperation with target tissue facilitates
healing and avoids unwanted side effects such as calcification or
infection at the interventional site.
[0126] Subsequent to the interventional procedure, the patient can
be directed to take alpha blockers for 2-4 weeks. Anti-inflammatory
medicine can also be taken.
[0127] A multi-centre single-arm, prospective, non-randomized study
in the context of improving LUTS for the purpose of improving
sexual function was performed to evaluate the feasibility and
safety of the anchor implantation procedure. Patients were treated
by a single urologist who has received in-service training for the
procedure prior to the commencement of the study.
[0128] Male subjects were enrolled in this study if they met the
following inclusion criteria: 1) diagnosis of lateral lobe
symptomatic BPH., 2) >54 years, 3) IPSS Symptom score >13, 4)
peak urine flow rate (Qmax) >5 ml/sec-<12 ml/sec on a voided
volume >125 ml., 5) prostate volume >20 gm, <100 gm, 6)
anesthesia risk group ASA class I-III, 7) normal microscopic
urinalysis and 8) a stable PSA over previous two years, or had a
pre-treatment transrectal ultrasound and prostate tissue biopsy, if
clinically indicated in the opinion of the investigator. If a
prostate tissue biopsy had been performed within 6 months of the
treatment date, then a further biopsy was not required.
[0129] The exclusion criteria included:
[0130] a. Mental capacity, dementia or inability to give informed
consent.
[0131] b. Subject in retention, or with previous history of urinary
retention.
[0132] c. Post void residual volume >250 ml by transabdominal
ultrasound.
[0133] d. Prostate gland with obstructive median lobe or prominent
bladder neck requiring intervention.
[0134] e. History of illness/symptoms or surgery that may confound
results of study, or pose additional risk to subject.
[0135] f. Patient with a life expectancy of less than 2 years.
[0136] g. Previous prostate surgery, dilatation, stent, laser,
hyperthermia (i.e. non-pharmaceutical prostate treatment).
[0137] h. PSA>10 ng/ml.
[0138] i. Known, or suspected urological conditions which may
effect voiding function such as confirmed or suspected malignancy
of the bladder or prostate, previous pelvic irradiation or radical
pelvic surgery, neurogenic bladder and/or sphincter abnormalities,
cystolithiasis or haematuria within 3 months, urinary tract
infection, urethral strictures, bladder neck contracture, active
clinical prostatitis, bladder pathologies or diabetes mellitus
affecting bladder function.
[0139] j. Compromised renal function (serum creatinine >1.58
mg/l or 0.1 mmol/L) (ref: medcalc version 5.3 palm/os.)
(medcalc.med-ia.net)
[0140] k. Previous rectal surgery, other than hemorrhoidectomy,
that could have distorted the pelvic anatomy, or any implants in
the pelvic/femoral region.
[0141] l. Subject interested in future fertility.
[0142] m. Concomitant medications: including .beta.-blockers,
antihistaminics, anticonvulsants, and antispasmodics within 1 week
of treatment unless there is documented evidence that the subject
has been on the same drug dose for at least 6 months with a stable
voiding pattern (the drug dose should not be altered or
discontinued for entrance into or throughout the study).
[0143] n. Anti-coagulant medication other than ASA or clopidogrel.
ASA and clopidogrel must be ceased 7 days prior to the
procedure.
[0144] o. 5-.alpha.-reductase inhibitors within 6 months of pre
treatment evaluation unless there was documented evidence that the
subject has been on the same drug dose for at least 6 months with a
stable voiding pattern (the drug dose should not be altered or
discontinued for entrance into or throughout the study). p.
Antidepressants, anticholinergics, or a -blockers within 1 week of
the pretreatment evaluation.
[0145] q. Anti-androgens or GnRH analogs within 2 months of
pretreatment evaluation.
[0146] r. Any abnormal coagulopathy.
[0147] s. Evidence of current UTI.
[0148] t. Evidence of current infectious process.
[0149] Erectile function was assessed by the 5 question version of
the International Index of Erectile Function (IIEF-5, or SHIM-5).
Ejaculation function was assessed by the Male Sexual Health
Questionnaire (MSHQ). An initial post-operative assessment was
completed before hospital discharge or within 48 hours. Patient
follow-up visits were scheduled at 2 weeks, 6 weeks, 3 months, and
6 months post treatment.
[0150] Results of the multi-center single-arm, prospective,
non-randomized study are shown in FIGS. 74-76. The mean baseline
score for the erectile questions of the IIEF was 13.76
demonstrating moderate to severe ED. At 6 weeks, 3 months, and 6
months the mean scores were 16.67, 17.46, and 16.50 respectively
(p<0.05). The mean baseline score for the MHSQ questions 1-3 was
9.48. At 6 weeks, 3 months, and 6 months the mean scores were
11.63, 11.83, and 11.05 (respectively) (p<0.05). The mean score
for the MSHQ question pertaining to bother was 1.52. At 6 weeks, 3
months, and 6 months the mean scores were 0.85, 0.83, and 0.74
(respectively) (p<0.05). Accordingly, improvements in sexual
function were exhibited as a result of the presently disclosed
anchor implantation procedure.
[0151] Furthermore, in addition to an intention to cooperate with
natural tissue anatomy, the present invention also contemplates
approaches to accelerate healing or induce scarring. Manners in
which healing can be promoted can include employing abrasive
materials, textured connectors, biologics and drugs.
[0152] It has been observed that placing the anchors at various
desired positions within anatomy can extract the best results. For
example, when treating a prostate, one portion of an anchor
assembly can be placed within an urethra and a second component
beyond the outer surface of the prostate. It has been found that
implanting the anchor assemblies by using the distal end of the
device to displace the prostate lobe on either side (while the
tension spring is taking up slack in the connector after the
delivery needle has been refracted) while deploying the second
anchor component so that the ten o'clock and two o'clock positions
(when looking along the axis of the urethra) are supported or
retained, effectively holds the anatomy open and also facilitates
invagination of the anchor portion within natural tissue.
Typically, one to two pairs of anchor assemblies are implanted to
create an anterior channel along the urethra within the prostate
gland (See FIG. 73). This is particularly true in the regions of
anatomy near the bladder and the juncture at which the ejaculatory
duct connects to the urethra.
[0153] Additionally, it is contemplated that the components of the
anchor assembly or selected portions thereof (of any of the anchor
assemblies described or contemplated), can be coated or embedded
with therapeutic or diagnostic substances (e.g. drugs or
therapeutic agents). Again, in the context of treating a prostate
gland, the anchor assembly can be coated or imbedded with
substances such as 5-alpha-reductase which cause the prostate to
decrease in size. Other substances contemplated include but are not
limited to phytochemicals generally, alpha-1a-adrenergic receptor
blocking agents, smooth muscle relaxants, and agents that inhibit
the conversion of testosterone to dihydrotestosterone. In one
particular approach, the connector 95 can for example, be coated
with a polymer matrix or gel coating which retains the therapeutic
or diagnostic substance and facilitates accomplishing the timed
release thereof. Additionally, it is contemplated that
bacteriostatic coatings as well as analgesics and antibiotics for
prostatitis and other chemical coatings for cancer treatment, can
be applied to various portions of the anchor assemblies described
herein. Such coatings can have various thicknesses or a specific
thickness such that it along with the connector itself matches the
profile of a cylindrical portion of an anchor member affixed to the
connector. Moreover, the co-delivery of a therapeutic or diagnostic
gel or other substances through the implant deployment device or
another medical device (i.e. catheter), and moreover an anchor
assembly including the same, is within the scope of the present
invention as is radio-loading devices (such as a capsular or distal
ends of implants for cancer or other treatment modalities). In one
such approach, the deployment device includes a reservoir holding
the gel substance and through which an anchor device can be advance
to pick up a desired quantity of therapeutic or diagnostic gel
substance.
[0154] It is to be recognized that the timing of the dual
advancement of the needle and connector assemblies and subsequent
relative motion between the assemblies is coordinated. That is, the
needle assembly first provides access to an interventional site and
then the connector assembly is left extending beyond a terminal end
of the needle assembly through the relative motion of the needle
and connector assemblies.
[0155] It is further contemplated that in certain embodiments, the
anchor delivery device can include the ability to detect forces
being applied thereby or other environmental conditions. Various
sections of the device can include such devices and in one
contemplated approach sensors can be placed along the needle
assembly. In this way, an operator can detect for example, whether
the needle has breached the target anatomical structure at the
interventional site and the extent to which such breaching has
occurred. Other sensors which can detect particular environmental
features can also be employed such as blood or other chemical or
constituent sensors. Moreover, one or more pressure sensors or
sensors providing feedback on the state of deployment of the anchor
assembly during delivery or after implantation are contemplated.
For example, tension or depth feedback can be monitored by these
sensors. Further, such sensors can be incorporated into the anchor
assembly itself, other structure of the deployment device or in the
anatomy.
[0156] Moreover, it is to be recognized that the foregoing
procedure is reversible. In one approach, the connection of an
anchor assembly can be severed and a proximal (or second) anchor
component removed from the patient's body. For example, the
physician can cut the connector and simultaneously remove the
second anchor previously implanted for example, in the patient's
urethra using electrosurgical, surgical or laser surgical devices
used in performing transurethral prostate resection.
[0157] An aspect that the various embodiments of the present
invention provide is the ability to deliver an anchor assembly
having a customizable length, each anchor assembly being implanted
at a different location without having to remove the device from
the patient. Other aspects of the various embodiments of the
present invention are load-based delivery, of an anchor assembly,
anchor assembly delivery with a device having integrated connector,
(e.g. suture), cutting, and anchor assembly delivery with an
endoscope in the device. The delivery device is uniquely configured
to hold the suture with tension during delivery to help ensure that
the first anchor component sits firmly against a tissue plane
(e.g., the outer capsule of the prostate) and is held relatively
firm as the second anchor component is attached to the connector
and the delivery device. In this aspect, the needle assembly acting
as a penetrating member is cooperatively connected to a mechanism
which pulls on the anchor while the needle assembly is
retracted.
[0158] It is to be recognized that various materials are within the
scope of the present invention for manufacturing the disclosed
devices. Moreover, one or more components such as distal anchor,
proximal anchor, and connector, of the one or more anchor devices
disclosed herein can be completely or partially biodegradable or
biofragmentable.
[0159] Further, as stated, the devices and methods disclosed herein
can be used to treat a variety of pathologies in a variety of
lumens or organs comprising a cavity or a wall. Examples of such
lumens or organs include, but are not limited to urethra, bowel,
stomach, esophagus, trachea, bronchii, bronchial passageways, veins
(e.g. for treating varicose veins or valvular insufficiency),
arteries, lymphatic vessels, ureters, bladder, cardiac atria or
ventricles, uterus, fallopian tubes, etc.
[0160] Finally, it is to be appreciated that the invention has been
described hereabove with reference to certain examples or
embodiments of the invention but that various additions, deletions,
alterations and modifications may be made to those examples and
embodiments without departing from the intended spirit and scope of
the invention. For example, any element or attribute of one
embodiment or example may be incorporated into or used with another
embodiment or example, unless to do so would render the embodiment
or example unpatentable or unsuitable for its intended use. Also,
for example, where the steps of a method are described or listed in
a particular order, the order of such steps may be changed unless
to do so would render the method unpatentable or unsuitable for its
intended use. All reasonable additions, deletions, modifications
and alterations are to be considered equivalents of the described
examples and embodiments and are to be included within the scope of
the following claims.
[0161] Thus, it will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without parting from
the spirit and scope of the invention.
* * * * *